Impax Submits New Drug Application for IPX066 in Parkinson’s Disease; VIVUS Reports Topline Findings From FORTRESS Print E-mail
By Staff and Wire Reports   
Wednesday, 21 December 2011 19:06
Below is a look at some of the headlines for companies that made news in the healthcare sector on December 21, 2011.

Impax Pharmaceuticals, the branded products division of Impax Laboratories, Inc. (NASDAQ: IPXL) announced the submission of Impaxs New Drug Application (NDA) for IPX066 to the U.S. Food and Drug Administration (FDA) for the treatment of idiopathic Parkinsons disease (PD). IPX066 is a patented extended release capsule formulation of carbidopa-levodopa (CD-LD). IPX066 is being developed in collaboration with GlaxoSmithKline (NYSE:GSK) for territories outside the U.S. and Taiwan.

In just three and a half years, Impaxs brand research and development team has successfully advanced IPX066 from an Investigational New Drug (IND) through multiple clinical studies of efficacy and safety, culminating in our NDA submission, said Michael Nestor, president of Impax Pharmaceuticals. This event demonstrates our strong internal capability to develop neurology products to fulfill unmet clinical needs of the PD community. IPX066 represents a significant commercial opportunity for Impax (IPXL) in the U.S., which if approved we plan to commercialize with our specialty neurology sales team.

IPX066 has undergone extensive clinical development, including multiple studies in early and advanced PD in the U.S. and in Europe. As agreed with the FDA, the NDA is being submitted as a 505(b)(2) application and includes data from three controlled Phase III studies and two open label extensions of IPX066 in early and advanced PD. In these studies, IPX066 has been studied in about 900 PD subjects. Impax held an end of Phase III meeting with the U.S. FDA in the third quarter of 2011 and is submitting its NDA consistent with the guidance it received.


announced topline preliminary results from its retrospective study of medical claims data on oral clefts (OC) associated with topiramate exposure in utero.  The study, known as FORTRESS for Fetal Outcome Retrospective TopiRamate ExpoSure Study, identified 1,945 mother-infant dyads exposed to topiramate either alone (monotherapy) or in combination with other antiepileptic agents (polytherapy) in the first trimester of pregnancy (the "Total Topiramate Cohort").

Among the Total Topiramate Cohort, 1,740 dyads were exposed to topiramate monotherapy (the "Topiramate Monotherapy Cohort"). There were 5 oral clefts in the Topiramate Monotherapy Cohort for a prevalence rate of 0.29% (5/1,740).  This prevalence rate was compared to a control group of infants of women who had previously taken antiepileptic drugs including topiramate but not during the pregnancy of interest (the "Formerly Exposed Cohort").  The prevalence rate for the Formerly Exposed Cohort was 0.16% (21/13,512). The prevalence ratio for Topiramate Monotherapy Cohort versus the Formerly Exposed Cohort was 1.88 (center-standardized, 95% CI 0.705.03).

"The prevalence ratio for oral clefts in FORTRESS is within the recently reported range for topiramate from several large studies," commented Peter Tam, president of VIVUS, Inc.  "We have shared these results with the FDA. We continue to work closely with the FDA during their review of the NDA and as we prepare for the upcoming Advisory Committee meeting expected in the first quarter of 2012."

The FORTRESS study analyzed data from the Total Topiramate Cohort, the Formerly Exposed Cohort, and a second control group, infants of women with similar medical profiles to the Total Topiramate Cohort regardless of prior antiepileptic drug use (the "Similar Medical Profile Cohort"). The Similar Medical Profile Cohort contained 13,614 dyads. In the Total Topiramate, Formerly Exposed, and Similar Medical Profile Cohorts there were 7, 21 and 9 oral clefts, respectively, for a prevalence of 0.36%, 0.16%, and 0.07%. Prevalence ratios standardized by center were 2.36 (95% CI: 0.99-5.59) for Total Topiramate Cohort versus the Formerly Exposed Cohort, and 5.44 (95% CI: 2.03-14.61) for Total Topiramate Cohort versus Similar Medical Profile Cohort. Results standardized by propensity score and site as well as results adjusting for other covariates, one at a time, yielded very similar results. One data source reported an unexpectedly low prevalence of oral clefts in the Similar Medical Profile Cohort.  

To evaluate this finding, investigators conducted post-hoc analyses that involved repeated re-sampling from the group of dyads who were eligible for this cohort.  Based on this re-sampling, the investigators determined that the oral clefts prevalence observed in the cohort was likely an artificially low estimate due to random error, suggesting that the observed prevalence ratio for the Total Topiramate Cohort versus the Similar Medical Profile Cohort is an over-estimate.

As part of FORTRESS, Major Congenital Malformations, or MCMs, are being evaluated. The MCM analysis is ongoing.  The FORTRESS findings are based on a claims-only analysis.  All of the results of the study are considered to be preliminary until the results are validated. The results will be final when validation is completed, which is expected in the third quarter of 2012.

Also Wednesday:

Adeona Pharmaceuticals, Inc. (NYSE Amex: AEN)
, (the "Company") announced today that the Board of Directors has taken several actions to prioritize the Company's focus on its recent entry into the emerging field of synthetic biology.

Agilent Technologies Inc. (NYSE: A)
today announced it has completed the acquisition of the BioSystem Development business.

Allos Therapeutics, Inc. (NASDAQ: ALTH)
, a biopharmaceutical company committed to the development and commercialization of innovative anti-cancer therapeutics, today announced that members of the Company’s senior management will present at the 30th Annual J.P. Morgan Healthcare Conference.

Anika Therapeutics, Inc. (NASDAQ:ANIK)
today announced the signing of an exclusive, multi-year U.S. licensing and supply agreement with DePuy Mitek, Inc., a leading orthopedic sports medicine company, for Anika’s MONOVISC®, a highly purified, high molecular weight form of hyaluronic acid for treating pain in patients suffering from osteoarthritis of the knee.

Baxter International Inc. (NYSE: BAX)
announced today that it will present at the 30th Annual J.P. Morgan Health Care Conference on Tuesday, January 10, 2012, at 2:30 p.m. (PT) or 5:30 p.m. (ET).

today announces an update on progress on a Digital Strip Reader ("DSR"), one of the three core Point Of Care ("POC") diagnostic device technologies owned by its 63% owned subsidiary, Bio-AMD Limited.

BioTime, Inc. (NYSE Amex: BTX)
today announced agreements with USCN Life Science, Inc. (USCN) of Wuhan, China, granting BioTime an option to license USCN’s antibody-producing cell lines and certain related technology that may be used by BioTime and its subsidiary OncoCyte Corporation for the large-scale manufacture of the antibody components of PanC-DxTM. PanC-DxTM is a novel diagnostic technology discovered at BioTime and OncoCyte that is intended to detect the presence of various human cancers, including cancers of the breast, lung, bladder, uterus, stomach, and colon, during routine check-ups.

Cannabis Science, Inc. (OTCBB: CBIS)
, a pioneering US biotech company developing pharmaceutical cannabis products, is pleased to release its analysis of the worldwide market potential for medical cannabis treatments of critical ailments.

Emergent BioSolutions Inc. (NYSE: EBS)
announced today that Fuad El-Hibri will retire as CEO effective April 1, 2012.

EpiCept Corporation (Nasdaq OMX Stockholm Exchange and OTCQX: EPCT)
today provided an update on the impact of the quality assurance review by the European Medicines Agency (EMA) of Ben Venue Laboratories on the availability of Ceplene® (histamine dihydrochloride).

Exelixis, Inc. (NASDAQ:EXEL) today announced that it has granted to Merck, known as MSD outside of the United States and Canada, an exclusive worldwide license to its PI3K-delta research and development program, including XL499, the company’s most advanced preclinical PI3K-delta inhibitor and other related compounds.

Generex Biotechnology Corporation (OTCBB: GNBT.OB) today announced that the previously announced Bloomberg Television segment on the Antigen Express breast cancer vaccine aired yesterday evening (December 20, 2011).

GenMark Diagnostics, Inc., (NASDAQ: GNMK) announced today that it has submitted to the U.S. Food and Drug Administration (FDA), for 510(k) clearance, a Respiratory Viral Panel for use on its eSensor® XT-8 system.

Integrated Management Information, Inc. (IMI Global) (OTCBB: INMG), a leading provider of verification and Internet solutions for the agricultural/livestock industry under the Where Food Comes From® brand, today announced that its president, Leann Saunders, appeared as an expert panelist on a special edition of NCBA's Cattlemen to Cattlemen TV show examining proposed animal disease traceability (ADT) regulations.

Crystal Research Associates, LLC announced today that it has issued an Executive Informational Overview® (EIO®) on InVivo Therapeutics Holdings Corp. (OTCBB: NVIV).

To help emerging and mid-size biopharmaceutical companies address an increasingly challenging regulatory and commercial environment, PAREXEL International (NASDAQ: PRXL), a leading global biopharmaceutical services provider, today announced that it is introducing a series of executive briefings with clinical operations and outsourcing leaders worldwide.

Repligen Corporation (NASDAQ: RGEN) announced today that it has submitted a New Drug Application (NDA) for SecreFlo™ (RG1068, synthetic human secretin) to improve detection of pancreatic duct abnormalities in combination with MRI in patients with pancreatitis.

On its conference call today, Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) provided its current outlook for non-GAAP financial performance for the full year ending December 31, 2012.

World Health Energy Holdings, Inc. (OTCQB: WHEN) (PINKSHEETS: WHEN)
, a public holding company developing joint venture partnerships for algae production for biodiesel and commercial fish food, announced today the signing of Letter of Intent with Prime Inc., an India Industrial and transport Company, to develop a biodiesel production facility ramping up to 250 acres with a budget of up to 100 million dollars.

ZIOPHARM Oncology, Inc. (Nasdaq: ZIOP) announced today that Jonathan Lewis, M.D., Ph.D., Chief Executive Officer, will present at the upcoming 30th Annual J.P. Morgan Healthcare Conference on Wednesday, January 11, 2012, at 2:30 pm Pacific Time, at the Westin St. Francis Hotel in San Francisco, CA.

"Featured Content" profiles are meant to provide awareness of these companies to investors in the small-cap and growth equity community and should not in any way come across as a recommendation to buy, sell or hold these securities. BiomedReports is not paid or compensated by newswires to disseminate or report news and developments about publicly traded companies, but may from time to time receive compensation for advertising, data, analytics and investor relation services from various entities and firms. Full disclosures should be read in the 'About Us Section'.

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